Surgical prosthesis-forming device used to implant an organ support in a mammal

ABSTRACT

The invention concerns a surgical device forming a surgical prosthesis.  
     This device is characterized in that it contains at least one first sling ( 20 ), at least one first traction component ( 30 ), and at least one first fixation or anchoring system ( 40 ), designed to work in concert with at least said first traction component ( 30 ), which includes a cage-forming device ( 42 ), the upper end ( 43 ) of which is fitted with a sliding component ( 46 ) which makes it easier to pull on the traction component ( 30 ) which acts on the sling ( 20 ), so that said pulling effects translation of one end of the sling ( 20 ). The device is preferably intended for the treatment of urinary incontinence in female mammals, in particular the human female.

This invention essentially concerns a surgical instrument forming asurgical prosthesis, designed to effect the implantation of a means ofsupport for a mammalian organ. Within the scope of the invention, anymammalian organ which can be supported can be treated using the surgicalinstrument according to the invention. The invention is particularlysuitable for the support of pelvic organs: the urethra, the bladder, thevagina, the cervix of the uterus, the uterus and the rectum. Theinvention preferably concerns a surgical instrument forming a surgicalprosthesis to support the urethra in treatment of urinary incontinence,in particular in female mammals and preferably in the human female.

The instrument corresponding to a surgical prosthesis according to thisinvention can be used to fix or keep in place various different tissuesor organs, with more or less significant modifications as dictated byanatomical and pathological considerations.

STATE OF THE ART

It is known that stress urinary incontinence is the consequence ofexcessive displacement of the urethra when pressure is generated withinthe abdomen as a result of coughing, laughing, physical exertion or,more generally, any form of abdominal strain.

The greater the mobility of the urethra, the more likely and the morecopious the leakage of urine, to the point that the canal may be in apermanent state of ptosis.

The incontinence may be associated with a variable degree of prolapse ofthe organs of the pelvis (i.e. the vagina, the uterus, the bladder orthe rectum), or it may be uncomplicated. It is in almost all cases theresult—more or less delayed—of vaginal delivery.

It is a major problem which seriously compromises the freedom anddignity of mothers. The fact that it is often kept secret makes itdifficult to study the associated morbidity.

On the other hand—and this is an important point—it is not a fataldisease so its treatment is essentially symptomatic, with the physicianunder the onus of seeking a perfect, complication-free outcome with theleast aggressive modalities possible.

A first step forward was made with the development of the so-called TVT(Tension-free Vaginal Tape) which represents a modern version of thestrip traditionally used to support the urethra from underneath. Theinnovation consists in producing the band in polypropylene, awell-characterized material, especially in hernial prostheses. Moreover,the implantation procedure for such a device is minimally invasive.

Document EP-A-0 248 544 describes an instrument corresponding to asurgical prosthesis to correct female incontinence, consisting of a bodymade of a cross-linked synthetic polymer hydrogel with some form oflocal reinforcement such as a netting made of plastic, e.g.polypropylene (see column 3, lines 39 to 46).

The body of the device is suspended by means of either sutures insertedin para-urethral pelvic tissue or using a long needle at the anteriorabdominal wall (column 4, lines 1 to 19, and FIGS. 2 to 4).

Furthermore, documents U.S. Pat. No. 5,899,909 and WO 02/30293 describean instrument and a treatment procedure for female urinary incontinence,and in particular a surgical implant comprising a strip designed to bepositioned below the urethra to prevent incontinence, said strip workingin concert with two wires joined to each end of the strip, connectedopposite the strip to a needle-shaped anchoring device, and crossing thetissue of the abdominal wall or of the pelvic wall (rectus sheath).

Application WO 98/35632 relates to other embodiments of tension stripswith reinforcement at the ends provided by folding over of the edges ofthe strip on themselves, thereby doubling the thickness at those points.These can be anchored on the pelvic bone.

Such devices give very good outcomes but the implantation procedure ishighly invasive because of the size of the two needles used and thetissue damage entailed by their passage.

The unacceptable incidence of complications and mortality associatedwith this kind of procedure has attracted extensive media attention,especially in France, and the modality has not significantly spread inother countries. In practice, the procedure is not easily reproducibleand the operator learning curve is not as steep as might have beenhoped.

PURPOSE OF THE INVENTION

The main purpose of this invention is to resolve the current technicalproblem by making available a surgical device forming a surgicalprosthesis to immobilize and support a physiological organ, notably tosupport the urethra to correct urinary incontinence, in particular infemale mammals, preferably human females, the implantation of saiddevice being a less aggressive procedure than that for prior devicesthus cutting down or more or less eliminating the risk of seriouscomplications.

Another main purpose of this invention is to resolve the currenttechnical problem by making available a surgical device forming asurgical prosthesis to immobilize and support any mammalian organ whichcan be supported, which might particularly advantageously be adapted tothe support of pelvic organs such as the urethra, the bladder, thevagina, the uterine cervix, the uterus and the rectum.

Another main purpose of this invention is to resolve the currenttechnical problem by means of a device which can be implanted in asurgical procedure to provide immobilization and support in a shortoperation which can be performed under local anesthesia without the needfor either admission into a hospital setting or post-operative bed-rest,and which can therefore be performed in an outpatient context.

This invention makes it possible for the first time to resolve thesetechnical problems in a simple, reliable way which is reproducible atthe industrial and medical scales, simplifying the surgical procedure bymaking it possible to perform the implantation operation under localanesthesia without either admission into hospital or post-operativebed-rest.

Thus, according to a first aspect, this invention provides a surgicaldevice forming a surgical prosthesis designed to provide support to amammalian organ that can be supported, notably to correct urinaryincontinence, characterized in that it comprises:

-   -   a) at least one first support component to provide support of        elongated shape defining a first and a second end, designed to        exert a supporting action on said physiological organ; said        first support component being made at least partially of a        substantially inextensible but flexible and deformable material;    -   b) at least one first traction component, advantageously        filiform, which can be connected at least temporarily with at        least one end of said first elongated support component, made of        a substantially inextensible material, which allows the pulling        and maintenance in place of said first elongated sling in such a        position that it can provide said support;    -   c) at least one first immobilization or anchoring system,        designed to work in concert with said first traction component,        inextensible, in such a way as to allow the fixation and        maintenance in place of said first elongated sling.

Said first anchoring system comprises a device which forms a cage withan upper end and a lower end, the upper end being fitted with a slidingcomponent which facilitates pulling on the traction component which actson the elongated sling to effect—through said pulling—the translation ofone end of the elongated sling in order to provide support to said organand/or to keep said organ in position.

According to an advantageous embodiment of the invention, said lower endof the anchoring system is configured to be inserted on or attached to amammalian substrate which is relatively resistant to tearing, e.g. boneor some other appropriate tissue. In the case of an embodiment toprovide support to correct urinary incontinence, the lower end of theanchoring system is preferably inserted on the pubic bone, or on thetissue of the wall of the hypogastrium, the pelvic cavity, or possiblythe abdomen.

According to another advantageous embodiment of the invention, the upperpart and the lower part of the cage-forming component of the anchoringsystem are joined to one another by several lateral bridging arms madeof a substantially inextensible but flexible and deformable material.

Advantageously, said lateral bridging arms are long enough tosubstantially form a kink at their mid-point, in such a way that theupper part folds back in the direction of the lower part with the partof the arm joined to the lower part thus being also inserted on theabove-mentioned mammalian substrate which is relatively resistant totearing, e.g. bone or some other appropriate tissue. Thus the anchoringsystem is inserted on a large area of the mammalian substrate which isresistant to tearing, thereby further restricting or preventing tearingthereof: this is particularly advantageous if the substrate on which itis inserted includes mammalian tissue, and in particular if it concernsthe tissue of the wall of the hypogastrium, the pelvic cavity orpossibly the abdomen.

According to an advantageous embodiment of the invention, thecage-shaped sliding component of the anchoring system is configured soas to act like a pulley, around which the traction component can slideor translate to pull on the elongated sling.

According to a particularly advantageous embodiment of theinvention—which is patentable in and of itself—the traction component isin the form of a traction wire, preferably including a sliding componentsuch as a ring or a loop at one end. The other end of the wire—the freeend—an be inserted into this ring or loop in such a way as to create alasso-like loop device to facilitate pulling on the elongated sling. Inthis case, the elongated sling preferably has at least one hole throughwhich said traction wire can be passed to be trapped by the lasso-typedevice so that, when the other end of the wire—the free end—is pulledon, the result is the translation of said end of the elongated sling(e.g. a strip).

According to another particularly advantageous embodiment of theinvention, the device could be configured so that both ends of theelongated sling (e.g. a strip) could be pulled on simultaneously by asingle anchoring system.

Moreover, a first anchoring system joined to one end of the elongatedsling (e.g. a strip) could be configured to allow fixation at apredetermined, set position, while the other end of the elongated sling(e.g. a strip) is joined to a second anchoring system according to thepresent invention, thereby allowing displacement of the second end—hereagain mobile—of the elongated sling in order to exert the desiredtraction on the mammalian organ as required.

According to another embodiment of the invention, the above-mentionedcage-forming device includes at its upper end a hollow, tubularcomponent, one end of which is designed to be joined to or continuouswith the upper part of the cage and, at the same time, to form thesliding component, in particular by presenting a surface which forms thepulley around which the traction wire is designed to slide;advantageously, said end has a hole which is coaxial with the hollowtubular component.

According to yet another embodiment of the invention, the lower part ofat least the first anchoring system or each anchoring system can includean annular part defining a central opening through which can be inserteda first traction component—advantageously filiform as mentioned above—oreach traction component. This annular part can also advantageously beused to insert the needle of a trocar to penetrate into the tissue.

Moreover, according to another advantageous embodiment, the upper partof at least one first anchoring system or of each anchoring system cancontain a hole through which the needle of a trocar can be inserted topenetrate the tissues. Thus, each anchoring system can be put inposition in a safe, reliable way inside a trocar between the trocar'spenetrating needle and an external sheath, in a direction which issubstantially axial to the anchoring system, as will be easilyunderstood by those skilled in the art, especially with reference to theappended FIG. 2 which will be described below.

According to a second aspect, this invention also covers as a novel,separately patentable product, the traction component itself as definedabove or as resulting from the following description, taken withreference to the drawings which represent an integral part of thisinvention and illustrate the description.

According to a particular modified embodiment of the invention, thefirst elongated sling is in the shape of a strip, of which at least thatpart which is located between its ends consists of a fabric or meshworkcreated from one or more wires made of a substantially inextensible butflexible and deformable material.

Advantageously, the material used to make the wire or wires comprisingthe fabric of the strip is an organic polymer which is compatible withimplantation in mammalian tissue, this organic material beingadvantageously one of the group of polyethylene, polypropylene or nylonand preferably polypropylene.

According to another modified embodiment of the invention, the firstand/or the second filiform traction component includes or consists of aninextensible traction wire, in particular a wire made of someinextensible material, e.g. an organic polymer which is compatible withlong-term implantation into mammalian tissue, in particularpolyethylene, polypropylene or nylon.

According to a third aspect, this invention also covers as a novel,separately patentable product, each fixation or anchoring system asdefined above or as resulting from the following description, taken withreference to the drawings which represent an integral part of thisinvention and illustrate the description.

As will be readily understood by those skilled in the art, thisinvention covers all characteristics which appear to be novel on thebasis of the description taken in its entirety together with thedrawings which represent an integral part of the invention, with respectto any background art, as much as a general means and in its generalfunction.

According to a fourth aspect, this invention also covers a fixation andanchoring kit characterized in that it includes at least one surgicaldevice forming a surgical prosthesis, according to one of the precedingaspects, together with an introducer instrument, advantageously in theform of a penetrating trocar, with a protective sheath for the fixationor anchoring system mounted in a compact way or folded back between thepenetrating trocar and the sheath, and joined to said sheath at least inthe direction of penetration, said sheath including a system to preventretrocession of the fixation system in place between the trocar and thesheath.

According to a fifth aspect, this invention also covers a surgicalmethod to provide support for an organ which requires support,characterized in that it comprises:

-   -   a) local anesthesia administered close to the organ requiring        support;    -   b) incision, and dissection of the tissue opposite and on either        side of the said mammalian organ requiring support;    -   c) insertion of the introducer instrument into the opening        created by said incision and dissection of the tissues on one        side and behind the organ requiring support, and after said        mammalian substrate which is relatively resistant to tearing        (e.g. bone or some other appropriate tissue) has been reached,        withdrawal of the protective sheath;    -   d) withdrawal of the penetrating trocar, notably of its needle        part;    -   e) simultaneous pulling on both ends of the advantageously        filiform traction component to install the fixation or anchoring        system in the correct place and open or deploy it, and        advantageously, in the preferred embodiment, to induce the        kinking at a minimum of two points of the bridging limbs to        allow a so-called umbrella-type positioning with a broad surface        of fixation or anchoring of the anchoring system;    -   f) repetition of preceding steps c), d) and e) on the other side        of the organ in order to introduce a second fixation system,        preferably identical to the first;    -   g) passage of one end of the traction component of the first        fixation system in a means of joining such as a hole in one        first end of the first elongated sling then into the sliding        component such as ring or loop of the other end of the filiform        traction component, in such a way as to create a lasso-like        loop, and a first pulling movement on the end or free part of        the traction component for preliminary positioning;    -   h) repeat of the same procedure as in the preceding step for the        second fixation system on the other side of the organ requiring        support, thereby preliminarily positioning the elongated sling        near the organ in question;    -   i) simultaneous pulling on both ends or free parts respectively        of the first traction component and of the second traction        component until there is tension being exerted on the first        elongated sling in the correct position in contact with said        organ to provide the desired support for said organ;    -   j) joining of the free ends respectively of the first filiform        component and the end of the second filiform component in the        ideal position, this joining of said end being carried out at        such a position that the organ being supported is not        compromised in any way;    -   k) closure of the incision with a suitable means of surgical        closure such as resorbable thread;

According to a preferred embodiment of this surgical procedure, it isused to correct incontinence in female mammals, in particular humanfemales. In this context, the organ to be supported is the urethra,preferably the part of the urethra close to the bladder. In thiscontext, it is preferred according to this invention that the anchoringsystems are inserted on tissue of the wall of the pelvic cavity,preferably substantially transversal tissues of the pelvic wall in thepart located between the urethra and the flank of the female mammal, inparticular a human female, above the vaginal wall.

In the drawings:

FIG. 1 shows from above a split diagram of the three main components ofthe surgical instrument forming a surgical prosthesis, including: atleast one first sling with an elongated configuration (e.g. a strip); atleast one first fixation or anchoring system including a cage-formingcomponent; and at least one first traction component, advantageouslyfiliform, preferably forming a lasso-like loop device as seen in FIG. 1in which two bridging arms (48) are indicated by broken lines;

FIG. 2 shows the first fixation or anchoring system fitted with at leastone first traction component, advantageously filiform, in place on apenetrating trocar, with an external protective sheath for surgicalpositioning;

FIG. 3 shows a diagrammatic representation of the deployed fixation oranchoring system, after withdrawal of both the protective sheath and thepenetrating trocar and the first pulling on the two ends of the filiformtraction component to kink the anchoring system with insertion on thesubstrate which is relatively resistant to tearing (e.g. bone or someother appropriate tissue);

FIG. 4 shows a cross-section through the line IV-IV in FIG. 3; and

FIG. 5 shows, according to the currently preferred surgical application,a mammalian organ being supported, specifically for the correction offemale incontinence with the urethra being supported.

Referring to FIG. 1, a surgical instrument forming a surgical prosthesisaccording to this invention is represented by the general referencenumber (10). This is designed to support a physiological mammalian organrequiring such support. The preferred embodiment represented isspecifically intended for the correction of urinary incontinence,particularly urinary incontinence in female mammals, and preferably inthe human female.

This device (10) is characterized in that it comprises:

-   -   a) at least one first support component represented by the        general reference number (20), elongated in shape defining a        first end (22) and a second end (24). This first support        component (20) is designed to exert a supporting action on a        physiological mammalian organ requiring support such as the        urethra, as shown in FIG. 5.

This first support component (20) is made at least partly of a materialwhich is inextensible but flexible and deformable. Preferably, it isentirely made out this inextensible material.

-   -   b) at least one first traction component (30), advantageously        filiform, e.g. including a wire or a torus formed by several        wires, which can be joined at least temporarily to at least one        end (22 or 24) of said first elongated support component. This        first traction component (30) can be made of a substantially        inextensible material which can pull the elongated sling        component (20) and keep it in a position in which it provides        said support, as is easily understood from the preceding and        following descriptions with reference to FIGS. 3 to 5.    -   c) at least one first fixation or anchoring system represented        by the general reference number (40), designed to work in        concert with said first traction component (30), inextensible,        in such a way as to fix said first elongated sling component        (20) and keep said sling component (20) in the correct position.

The anchoring system (40) preferably includes a cage-forming componentrepresented by general reference number (42) which includes an upperpart (43) and a lower part (44), the upper part (43) being fitted with asliding component (46) to facilitate pulling of the traction component(30) which acts on the elongated sling component (20), in order toeffect by means of said pulling the translation of one end (22 or 24) ofthe elongated sling component in order to support said organ andsubsequently keep it in the correct position.

According to a particular modified embodiment of the invention as shown,the first elongated support component (20) or sling is in the shape of astrip (21), with at least the part between its ends consisting of afabric or meshwork created from one or more wires made of asubstantially inextensible but flexible and deformable material. Thoseskilled in the art are familiar with the production of such strips whichis described in the documents cited in the prior art. Particularreference could be made to document WO 98/35632 which describes variousalternative embodiments, with areas of reinforcement generated byfolding back of the ends as shown in FIG. 6 (FIGS. 6A to 6O), or inFIGS. 7 to 9 in this document.

The dimensions of the strip are also described in detail in the priorart, notably in document WO 98/35632 (from page 7, line 22 to page 15,line 33).

In the context of the present invention, the material used to make thewire or wires comprising the fabric or the strip is preferably anorganic polymer which is compatible with implantation in mammaliantissue, this organic material being advantageously one of the group ofpolyethylene, polypropylene or nylon and preferably polypropylene.

In the context of the invention, the ends (22 and 24) advantageouslyinclude at least one area of reinforcement such as (23), (25) formed bya different kind of weave, either advantageously of a single orpreferably of at least two folds of the strip back upon itself in such away as to provide a double or even a triple thickness. Then, means ofjoining—if only temporary—could be created with the traction components(30) such as an opening respectively (26, 27) for each end (22, 24).

In the context of the invention, according to an advantageousembodiment—which is patentable in and of itself—the traction component(30) is in the form of a traction wire, preferably including a slidingcomponent (32) such as a ring or a loop at one end (31) formed by meansof creating a node on the appropriate wire. The other end of the wire(33)—the free end—can be inserted into this ring or loop in such a wayas to create a lasso-like loop device as would be easy to understand forthose skilled in the art, thereby facilitating pulling on the elongatedsling (20) as is explained below. In this case, as has already beendescribed, the sling contains at least one opening (26 or 27) throughwhich the traction wire (30) can be inserted in such a way that thecorresponding end—here (21) in FIG. 1—of the sling (20) is trapped bythe lasso-like device. Thus, by pulling on the other end or free part(33) in the direction of the indicated arrow A, the translation of theend (22) of the sling (20) (e.g. a strip as here) can be effected.

The anchoring system (40)—which is patentable in and of itself—will nowbe described in greater detail. This includes a cage-forming device (42)which according to a preferred embodiment includes at its upper end (43)a sliding component (46) which could for example be formed by a hollow,tubular component (47), one end of which (47 a) is designed to be joinedto or continuous with (as shown) said upper part (43) of the cage (42)and, at the same time, to form said sliding component (46), inparticular by presenting a surface which forms the displacement orsliding pulley around which the previously mentioned traction wire (30)is designed to slide, as shown in FIG. 1. The end (47 a) here iscontinuous with the upper end (43) which also contains a throat (62)forming a surface over which the sliding component (46) can move. Theend (47 a) contains a hole (60) which is coaxial with the hollow tubularcomponent (47), the whole here constituting a single unit which includesthe upper end (43) of the cage (42).

Thus, the opening (60) of the upper end (43) of the cage-forming device(42) is specifically designed to receive the needle (113) of thetrocar-forming introducer device described below with reference to FIG.2. Those skilled in the art will also understand that the opening iscoaxial with the hole defined by the hollow tubular component (47), sothat it can be used to guide the needle (113) of the trocar-formingintroducer device, as will also be described with reference to FIG. 2.

According to an advantageous embodiment of the invention, the upper part(43) and the lower part (44) of the cage (42) are joined to one anotherby several lateral bridging arms (48), e.g. four such arms as in FIG. 2where two of the arms are represented by broken lines. These arms—likethe rest of the cage and all the other components of the invention—aremade of some physiologically compatible, inextensible material. Thismaterial is preferably a biocompatible organic material advantageouslyone of the group of polyethylene, polypropylene or nylon, and preferablypolypropylene

Advantageously, the length of the bridging arms (48) is such that theyreadily kink when the traction component (30) is pulled, the beginningof this kinking process being shown in the diagram in FIG. 1. Thekinking usually occurs around the mid-point (48 a) of the arm (48), aswill be evident to those skilled in the art. This makes it possible (asshown in FIGS. 3 and 4) to obtain umbrella-like deformation of theanchoring device in which the lower parts of the arms below the kinkpoint (48 a) create an extensive surface for insertion of the anchoringdevice on the substrate tissue, thereby reducing or even preventingtearing thereof, as will be explained below.

According to the shown, preferred embodiment, the lower part (44) of theanchoring device (40) is ring-shaped (49) with a central hole (50)through which the two parts of the lasso-like wire can be passed.Obviously, the ring shape is not limiting and diverse configurations arepossible. Advantageously, the lower part should be relatively solid inorder to constitute a solid base to facilitate kinking of the lateralbridging arms (48).

FIG. 2 shows the introducer device (100) which on one side includes apenetrating trocar (110) made up of a needle (112) with a tapered distalpart (113), and a flaring proximal part (114) which forms a shoulder forpushing. This introducer device (100) also includes an external sheath(120) as is classic in trocar introducer systems. The diameter of thissheath is sufficiently larger than that of the needle (112) to create achamber (122) to accommodate the anchoring device (40) in a foldedconfiguration, pre-fitted with the traction component (30) with itsfirst end (31) including the ring-shaped or looped sliding component(32), and the second free end (33), the two ends projecting out from thesheath far enough to be accessible to the surgeon once the introducerdevice has been introduced to the desired deployment position, generallyabove a support such as, for example, the transverse wall of the pelviccavity (150) as shown in FIG. 4. The rear part of the sheath couldadvantageously include a compression component (121) such as a screwdesigned to fix the sheath to the needle (112) during its advance, andcreate a means of preventing retrocession of the anchoring device (40).This type of introducer device based on a penetrating trocar and asheath is familiar to surgeons. The needle (112) is advantageouslyhollow and curved, and includes a bump or stop block (113 a) a fewcentimeters from the distal end designed to prevent retrocession of boththe anchoring device (40) when in position, and the needle (112) in thesheath (120). This short needle (112) includes at its proximal end theflared portion or shoulder (114) which is advantageously designed—forexample—to receive a syringe for the injection of anesthetic, theflaring making it possible for the operator to take hold of the needleso that it can be directed accurately, the importance of which isevident to surgeons.

FIGS. 3 and 4 give a representation of the end of the first stage of theinstallation of the anchoring device (40) which has been deployed byremoval first of the sheath and then of the needle (112). Alsorepresented diagrammatically is the end (22) of the sling (20) with thetraction component (30). A first end of the wire (31) of the latter (30)has been passed through the hole (26), and the other end of the wire(33) has been inserted in the ring-shaped or looped sliding component(32) in such a way as to form a lasso-like loop, as can be seen clearlyin FIG. 3 and as was shown previously in FIG. 1. Pulling on both ends ofthe traction component (30) at the same time induces the positioning andopening of the anchoring device (40) in a so-called umbrellaconfiguration, with kinking substantially at the midpoint (48 a) of eachbridging arm (48) in such a way that the lower parts (48 b) of the arms(58) constitute together a broad support surface and therefore providesolid anchoring of the anchoring system (40), without exerting anysubstantial shearing force on the substrate tissues and therefore notleading to tearing of said tissues. Those skilled in the art willunderstand that to provide the support to an organ that needs suchsupport such as the organ (200) shown in FIG. 5, here the urethra (202)according to the currently preferred application, the operator will haveto install—using the introducer device (100)—two fixation systems (40 aand 40 b), one on either side of the organ requiring support (200), herethe urethra (202).

The operator will also have to trap each end (22 and 24) of the sling(20) (e.g. a strip [21]) in the lasso system, as shown in FIG. 5, andthen pull, initially on the two ends of the traction component (33 a and33 b) for each anchoring system (40 a and 40 b) in such a way as todeploy and induce the kinking of the fixation systems (40 a and 40 b),here in a so-called umbrella configuration, in order that said fixationsystems (40 a and 40 b) are properly inserted on the substrate tissueswhich corresponds in the case shown to the transverse walls of thepelvic cavity (150) (see FIG. 4) opposite either side of the organrequiring support (200). This insures that the desired supporting roleis correctly mediated, as will be readily understood by those skilled inthe art, notably stemming from knowledge of the prior art as reported inthe documents cited in the paragraph on the background art presented atthe beginning of this description.

At the end of the pulling operation, the operator pulls each end (22 and24) of the sling (20) (e.g. a strip) and when sufficient supportingtraction force is being provided, the two free ends (33 a and 33 b) ofeach traction component (30 a and 30 b) are knotted, e.g. using a solidknot (210) which is preferably located outside of the support zone forthe organ (200), such as the urethra (202) as shown in FIG. 5.

This invention makes it possible to perform the corrective surgery in anoutpatient context with simple local anesthesia.

In the context of the treatment of incontinence in female mammals, inparticular the human female, a simple douche and routine vaginalhygienic measures suffice for pre-operative preparation. Neitherpre-medication nor per-operative infusion are necessary. Simple oralantibiotics suffice for prophylactic treatment.

With the patient in the gynecological position with her hips flexed atan angle of between 40 and 60°, the operator carries out the surgicalprocedure described above and also claimed. This surgical procedureincludes local anesthesia with about 20 cm³ of 0.5% Xylocaine on thevaginal mucosa at about one centimeter from the meatus, then laterally,and finally beyond the pelvic wall for hydrodissection. The operatorwill then make a 1-centimeter incision at a distance of one centimeterfrom the meatus.

Then para-urethral dissection is performed using scissors over threecentimeters as afar as the pelvic wall on the right and the urethra onthe left.

Then the introducer device is manually inserted under the intravaginalguidance of the fingers of the free hand. Through the incision, whileadvancing laterally in the detached tissue, the operator exerts mildpressure to broach the pelvic wall (150), then advances a further twocentimeters without exerting any force.

Then the sheath (120) is retracted followed by the trocar (110).

Simultaneously pulling on both ends (31 and 33) of each tractioncomponent (30) causes the anchoring device (40) to open like anumbrella, then after the end (31) has been passed through the hole (26)in the first sling (20) and the lasso-like loop has been created, asshown in FIG. 3, pulling on the end (33, 33 a or 33 b) (see FIGS. 3 and4) induces traction and the elongated sling (20) can be correctlypositioned. It should be noted that for certain forms of surgeryinvolving larger organs in the treatment of certain diseases, it may benecessary to use either more than one elongated sling component (20) ora single, broader elongated sling, at the discretion of the surgeon.

Within the scope of the invention, any mammalian organ which can besupported can be treated using the surgical device according to theinvention. The invention is particularly suitable for the support ofpelvic organs: the urethra, the bladder, the vagina, the cervix of theuterus, the uterus and the rectum.

It is also understood that the invention includes any means that aretechnically equivalent to those described as well as any combinationsthereof.

1-16. (canceled)
 17. A surgical device forming a surgical prosthesis,designed to provide support to a physiological, mammalian organ that canbe supported, comprising: a) at least one first support component toprovide support comprising a first elongated component or sling, with afirst end and a second end designed to exert a supporting action on saidphysiological mammalian organ requiring support; said first elongatedcomponent being made at least partially of a substantially inextensiblebut flexible and deformable material; b) at least one first tractioncomponent, which can be connected at least temporarily with at least oneend of said first elongated support component, made of a substantiallyinextensible material enabling to pull on the first elongated supportcomponent and maintain same in place in a position providing saidsupport; c) at least one first anchoring system, designed to cooperatewith at least said first traction component, to fix said first elongatedsupport component and keep same in the correct position; said firstanchoring system comprising a cage-forming device with an upper end anda lower end, the upper end being fitted with a sliding component whichenables to pull on the traction component which acts on the elongatedsupport component, to effect through said pulling the translation of oneend of the elongated support component to provide support to said organand keep said organ in support position.
 18. The device of claim 17,wherein the lower end of the anchoring system is configured to beinserted on or attached to a mammalian substrate which is relativelyresistant to tearing.
 19. The device of claim 17, wherein the upper partand the lower part of the cage-forming device of the anchoring systemare joined to one another by a series of lateral bridging arms made of asubstantially inextensible but flexible and deformable material.
 20. Thedevice of claim 19, wherein said lateral bridging arms are long enoughto substantially form a kink in the vicinity of their mid-point, in sucha way that the upper part folds back towards the lower end with the partof the arm joined to the lower end being also inserted on the mammaliansubstrate which is relatively resistant to tearing; thereby having theanchoring system inserted over a broad area of mammalian substrate whichis relatively resistant to tearing, with reduction of the risk oftearing thereof.
 21. The device of claim 17, wherein the slidingcomponent of the anchoring system is configured to act as a pulley,around which the traction component can slide or translate to pull onthe elongated support component.
 22. The device of claim 17, wherein thetraction component is in the form of a traction wire, having a first endand a second end, comprising a ring or loop at one of said first end andof said second end; the other of said first end and of said second endof the wire, named free end, cooperating with said ring or loop tocreate a lasso-like loop device to facilitate pulling on the elongatedsling.
 23. The device of claim 17, wherein a single anchoring system isprovided designed to simultaneously pull both ends of the elongatedsupport element.
 24. The device of claim 17, wherein the first anchoringsystem joined to a first end of the elongated support component isconfigured to allow fixation at a predetermined, set position, while thesecond end of the elongated support component is joined to a secondanchoring system, thereby allowing displacement of the second end of theelongated support component in order to exert a traction force on themammalian organ as required.
 25. The device of claim 17, wherein thecage-forming device comprises at its upper end a hollow, tubularcomponent having a first end which is designed to be joined to orcontinuous with said upper end of the cage and, at the same time, toform the sliding component by presenting a surface which forms thepulley around which the traction wire is designed to slide.
 26. Thedevice of claim 25, wherein said end of the tubular component has a holewhich is substantially coaxial with the hollow tubular component. 27.The device of claim 17, wherein the lower part of at least the firstanchoring system or of each anchoring system comprises an annular partdefining a central hole through which can be passed the first tractioncomponent or each traction component.
 28. The device of claim 27,wherein said central hole is designed to accommodate the needle of atrocar.
 29. The device of claim 17, wherein the first elongated supportcomponent is in the shape of a strip having a main part which is locatedbetween its ends consisting essentially of a fabric or meshwork createdfrom two or more wires made of a substantially inextensible but flexiblematerial.
 30. The device of claim 29, wherein the material of the wirescomprising the fabric of the strip is an organic polymer which iscompatible with implantation in mammalian tissue.
 31. The device ofclaim 30, wherein the organic material is selected from the groupconsisting of polyethylene, polypropylene and nylon.
 32. The device ofclaim 17, wherein the second inextensible traction component includes oris constituted of an inextensible traction wire made of an inextensibleorganic material which is compatible with long-term implantation inmammalian tissue.
 33. Traction component of the surgical device forminga surgical prosthesis as defined in claim 17, wherein said tractioncomponent is made of a substantially filiform inextensible material, andis connectable at least temporarily with at least one end of the firstelongated sling to allow the pulling of said elongated sling and keepsame in a position providing said support.
 34. Fixation or anchoringsystem of the surgical device forming a surgical prosthesis as definedin claim 17, wherein said anchoring system comprises a cage-formingdevice with an upper end and a lower end, the upper end being fittedwith a sliding component for pulling on the traction component whichacts on the elongated sling, in order to effect the translation of oneend of the elongated sling in order to provide support to said organ orkeep said organ in position.
 35. Fixation and anchoring kit comprisingat least one surgical device forming a surgical prosthesis as defined inclaim 17, together with an introducer instrument, in the form of apenetrating trocar, with a protective sheath for the fixation oranchoring system mounted in a compact way or folded back between thepenetrating trocar and the sheath, and joined to said sheath at least inthe direction of penetration, said sheath comprising a system to preventretrocession of the fixation system in place between the trocar and thesheath.
 36. A method to provide support for an organ which requiressupport, comprising: a) performing local anesthesia administered closeto the organ requiring support; b) performing incision, and dissectionof the tissue opposite and on either side of said mammalian organrequiring support to create an opening; c) inserting through saidopening at least one first elongated support component or sling asdefined in claim 17, and then an introducer penetrating trocarinstrument having a protective sheath and containing at least a firstanchoring system, cooperating with at least one traction component, bothas defined in claim 17, into the opening created by said incision anddissection of the tissues on one side and behind the organ requiringsupport, and after reaching said mammalian substrate which is relativelyresistant to tearing, withdrawal of the protective sheath; d)withdrawing the penetrating trocar; e) simultaneous pulling on both endsof the filiform traction component to install the anchoring system inthe correct place and open or deploy it; f) repeating preceding stepsc), d) and e) on the other side of the organ in order to introduce asecond fixation system, preferably identical to the first; g) passingone end of the traction component of the first fixation system in ameans of joining in one first end of the first elongated sling then intothe sliding component of the other end of the filiform tractioncomponent, to create a lasso-like loop, and a first pulling movement onthe end or free part of the traction component for preliminarypositioning; h) repeating the same procedure as in the preceding stepsfor the second fixation system on the other side of the organ requiringsupport, thereby preliminarily positioning the elongated sling near theorgan in question; i) simultaneous pulling on both ends or free partsrespectively of the first traction component and of the second tractioncomponent until there is tension being exerted on the first elongatedsling in the correct position in contact with said organ to provide thedesired support for said organ; j) joining of the free ends respectivelyof the first filiform component and the end of the second filiformcomponent in the appropriate position, this joining of said end beingcarried out at such a position that the organ being supported is notcompromised in any way; k) closure of the incision with a suitable meansof surgical closure.
 37. The method of claim 36, wherein the upper partand the lower part of the cage-forming device of the anchoring systemare joined to one another by a series of lateral bridging arms made of asubstantially inextensible but flexible and deformable material, saidarms being long enough to induce a kinking at the vicinity of theirmid-point to allow a so-called umbrella-type positioning with a broadsurface of fixation or anchoring of the anchoring system.
 38. The methodof claim 36, which is performed to correct incontinence in femalemammals.
 39. The method of claim 36, wherein the organ to be supportedis the urethra.
 40. The method of claim 36, wherein at least oneanchoring system is inserted on tissue of the wall of the pelvic cavity.